These are the ATS keywords, credentials, and software terms that recur across current biomedical engineer job descriptions — organized so you can scan for what your resume is missing. Placement matters as much as presence: an ATS keyword buried in a skills list ranks lower than the same term used in context inside an experience bullet.

Title variants

  • Biomedical Engineer
  • Medical Device Engineer
  • Design Engineer (Medical Devices)
  • R&D Engineer
  • Clinical Engineer
  • EBME Engineer
  • Regulatory Affairs Engineer
  • Quality Engineer (Medical Devices)
  • Biomechanical Engineer
  • In-Vitro Diagnostic Engineer
  • Software Engineer (Medical Devices)
  • Digital Health Engineer

Regulatory standards — Europe

  • EU MDR
  • MDR 2017/745
  • CE Mark
  • CE Marking
  • UKCA
  • Technical File
  • Annex II
  • Annex III
  • Clinical Evaluation Report
  • CER
  • Post-Market Surveillance
  • PMS
  • PMCF
  • UDI
  • EUDAMED
  • Notified Body
  • IVDR 2017/746

Regulatory standards — FDA

  • FDA
  • 510(k)
  • PMA
  • De Novo
  • FDA 21 CFR Part 820
  • QMSR
  • predicate device
  • substantial equivalence
  • FDA submission
  • FDA clearance

Quality management

  • ISO 13485
  • ISO 13485:2016
  • QMS
  • CAPA
  • NCR
  • design controls
  • Design History File
  • DHF
  • Device Master Record
  • DMR
  • Device History Record
  • DHR
  • audit
  • quality system

Risk management

  • ISO 14971
  • ISO 14971:2019
  • risk management
  • risk file
  • risk management file
  • FMEA
  • hazard analysis
  • hazard identification
  • risk estimation
  • risk control
  • residual risk
  • benefit-risk

Electrical safety and EMC

  • IEC 60601-1
  • IEC 60601-1-2
  • EMC
  • electromagnetic compatibility
  • electrical safety
  • applied part
  • patient leakage current
  • radiated emissions
  • conducted emissions
  • ESD
  • radiated immunity
  • Type B
  • Type BF
  • Type CF

Software lifecycle

  • IEC 62304
  • medical device software
  • SaMD
  • software as a medical device
  • software validation
  • verification and validation
  • V&V
  • software safety classification
  • IEC 62304 Class A/B/C

Biocompatibility

  • ISO 10993
  • ISO 10993-1
  • biological evaluation
  • biocompatibility
  • cytotoxicity
  • sensitisation
  • implant testing
  • genotoxicity

CAD and simulation

  • SolidWorks
  • CATIA V5
  • NX
  • Creo
  • Abaqus
  • ANSYS
  • FEBio
  • FEA
  • finite element analysis
  • biomechanics
  • fatigue analysis
  • fluid-structure interaction

Imaging and data

  • MATLAB
  • Python
  • LabVIEW
  • DICOM
  • HL7
  • FHIR
  • signal processing
  • image processing
  • medical imaging
  • PACS

Credentials

  • IPEM
  • MIPEM
  • FIBMS
  • CEng
  • IEng
  • IEEE EMBS

Long-tail phrases

  • biomedical engineer resume
  • biomedical engineer cv
  • how to write a biomedical engineer resume
  • biomedical engineer resume 2026
  • medical device engineer resume
  • regulatory affairs biomedical resume
  • EU MDR biomedical resume
  • ISO 14971 risk management resume

Pasting these terms into your resume verbatim without matching context can read as keyword stuffing to a human reviewer, even if it passes the ATS. The full Biomedical Engineer resume guide shows where each category belongs and how to work it into real experience bullets.